Under the direction of Management, the Specialist is responsible for researching, performing, and interpreting experiments in support of new hematology-focused diagnostic assay development and implementation, as well as troubleshooting and improving current diagnostic assays performed by the organization.

DUTIES AND RESPONSIBILITIES

MAJOR RESPONSIBILITIES

• Designs and participates in the development and implementation of new hematology-based clinical diagnostic assays
• Performs and interprets experiments independently in support of new assay development
• Troubleshoots and improves current diagnostic assays
• Presents experimental results and interpretation to department management and other project stakeholders
• Prepares and/or assists in the preparation of SOPs, lab development notebooks, development plans, validation plans and summaries, and other relevant documentation
• Trains clinical diagnostic lab staff on relevant assay execution
• Serves as a technical resource for lab(s) in area of specialized expertise
• Serves as liaison with internal and external partners to promote technology assessments and research, and facilitate technology transfer into respective lab(s)
• May serve as a team lead and/or subject matter expert on development projects 
• Maintains a current understanding of literature and presentations relevant to the organization’s clinical focus, and applies the acquired knowledge and skills in contributing to the structure and planning of research and development projects
• Performs specialized tests for laboratory-specific research, contract research, and other special projects, as needed

GENERAL DUTIES

• Prepares and/or participates in abstract and manuscript submissions and presentations
• Assists management in identifying and evaluating key new technologies and testing platforms. Participates in formal new product opportunity evaluations.
• Assists with equipment maintenance 
• Assists in quality and process improvements
• Interacts with vendors for quotes on, and ordering of, supplies, reagents, and equipment
• Supports annual and project-specific budgeting, as well as establishing test costing, by providing relevant information on supplies, reagents, and equipment

QUALIFICATIONS

Education

• Bachelor of Science from an accredited academic institution in Biology, Chemistry, Molecular Biology, Biochemistry, Microbiology, Immunology, or related field required. A PhD in any of these fields, or Master of Science with equivalent professional experience, is preferred.

Experience

• Minimum of 5 years test development or comparable laboratory experience required
• Clinical diagnostic assay development, validation, and/or implementation (or equivalent experience) required. Clinical diagnostic testing using next-generation sequencing (NGS) preferred
• Demonstrated direct laboratory experience (minimum of 3 years) in one or more of the following: nucleic acid work (DNA/RNA extraction, PCR, DNA/RNA sequencing [including NGS], digital PCR, etc.); flow cytometry; ELISA, chemiluminescence and/or similar technologies; serology/immunology; biochemical assays
• Experience in converting assays to new platforms (i.e., improved technology; high-throughput; etc.) preferred

Skills and Knowledge

Required

• Strong attention to detail; analytical ability to evaluate and ensure accuracy of data related to laboratory results and patient information
• Experimental design and execution
• Effective time management and organizational skills. Capable of planning, prioritizing and executing a broad base of laboratory functions and experiments, often across multiple simultaneous projects.
• Able to deliver on organizationally-defined timelines and effectively communicate progress, challenges, etc. to stakeholders
• Ability to work independently and as part of cross-functional teams
• Effective oral and written communication skills for both scientific and non-scientific audiences
• Demonstrated decision-making, problem-solving, troubleshooting skills
• Knowledge of Quality Control/Quality Assurance principles and Good Documentation Practices (GDP)
• Ability to train/transfer knowledge to other personnel (e.g., Standard Operating Procedure creation [SOP] and training)
• Skilled use in Microsoft Word, Excel, PowerPoint and/or similar software

Preferred

• Experience in multiplexed assay development
• Previous experience with Laboratory Information Management Systems
• Knowledge of Good Laboratory and current Good Manufacturing Practices (GLP, cGMP)
• Demonstrated project management experience
• Previous technical supervisor/team leader experience

Tools and Technology

• Personal Computer (desktop, laptop, tablet)
• General office equipment (computer, printer, fax, copy machine)
• Microsoft Suite (Word, Excel, PowerPoint)
• Automated DNA sequencers, q/dPCR instrumentation, spectrophotometers, flow cytometer, DNA arrays, multi-well plate readers and washers, pipets, centrifuges, photo documentation, automated liquid handling systems

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